Kornimate/medical-research-clean huggingface dataset:
mitigating delirium with fluvoxamine treatment for non-cardiac surgery

Conditions: Delirium; Surgery-Complications

Summary: the investigation will establish biological plausibility and infrastructure required for a multisite clinical trial evaluating the re-purposing of fluvoxamine to mitigate postoperative delirium risk in geriatric patients undergoing non-cardiac non-intracranial surgery.

delirium is a disturbance in attention, cognition, and consciousness, an acute physiological consequence of medical events, such as hospital admission, surgery, sepsis, and pharmacological intervention. there are currently no standard pharmacologic interventions to prevent delirium in any setting. the investigation will lay the groundwork for a larger-scale phase 3 trial geared toward advancing long-term goal of improving public health and quality of life for those at risk of postoperative delirium and related sequelae. the study assumes that neuroinflammation is a key contributor to the pathogenesis of postoperative delirium, a matter of conjecture. the investigators will directly test systemic inflammation as a proxy for neuroinflammation. the investigation will test whether fluvoxamine may be associated with reduced systemic inflammation, markers of neural dysfunction, and delirium severity. this potential therapeutic approach has potential generalizability to different clinical settings and already proved useful for covid-19. the investigators combine the need to develop a collaborative clinical trials platform across diverse healthcare settings with key mechanistic studies that will advance our understanding of the pathogenesis of delirium. these studies will leverage high-density eeg recordings and state-of-the-art plasma biomarker collection, providing key data on the biological plausibility for a fluvoxamine effect.

Eligibility criteria:
inclusion criteria: * english-speaking * elective non-cardiac or non-intracranial surgery requiring at least a 2-day hospital length of stay exclusion criteria: * received investigational drug within the last 7 weeks * lack of capacity to provide informed consent * prior known intolerance or allergy to ssris or fluvoxamine * planned postoperative ventilation * drug or alcohol dependence * preoperative use of non-nsaid medications with drug-drug interactions of class x (avoid combination) or d (consider therapy modification) * risk of serotonin syndrome (st john's wort, ssris, or tca)

Keywords: delirium geriatric surgery fluvoxamine
spleen-preserving no. 10 lymph node dissection in gastric cancer

Conditions: Overall Survival

Summary: this study is to conduct a randomized controlled trial of two kinds of radical gastrectomy for patients with proximal gastric cancer. one is laparoscopic d2 radical total gastrectomy combined with spleen-preserving no.10 lymph node dissection , another one is laparoscopic d2 radical total gastrectomy without clearing the no. 10 lymph nodes of the spleen. we explore the effect of the two procedures on the survival of patients, as well as the surgical complications associated with the two procedures, the number of lymph node dissection, the operation time and the amount of intraoperative blood loss. furthermore, we also want to discuss the application value of laparoscopic lymph node dissection for spleen preservation in radical gastrectomy for proximal gastric cancer.


Eligibility criteria:
inclusion criteria: 1. age from 18 to 80 years 2. primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. ct2-4a, n0-3, m0 at preoperative evaluation according to the american joint committee on cancer (ajcc) cancer staging manual seventh edition 4. no distant metastasis is observed. and the spleen, pancreas or other adjacent organs are not involved by the tumor. 5. performance status of 0 or 1 on eastern cooperative oncology group scale (ecog) 6. american society of anesthesiology score (asa) class i, ii, or iii 7. written informed consent exclusion criteria: 1. women during pregnancy or breast-feeding 2. severe mental disorder 3. history of previous upper abdominal surgery (except laparoscopic cholecystectomy) 4. history of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection 5. enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging 6. history of other malignant disease within past five years 7. history of previous neoadjuvant chemotherapy or radiotherapy 8. history of unstable angina or myocardial infarction within past six months 9. history of cerebrovascular accident within past six months 10. history of continuous systematic administration of corticosteroids within one month 11. requirement of simultaneous surgery for other disease 12. emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 13. fev1\<50% of predicted values
a study to learn about the study medicine called pf-08046032 in people with advanced cancers.

Conditions: Peripheral T Cell Lymphoma; Diffuse Large B-cell Lymphoma; Classical Hodgkin Lymphoma; Head and Neck Squamous Cell Carcinoma; Melanoma; Non-Small Cell Lung Cancer

Summary: the purpose of this study is to learn about the effects of a new study medicine called pf-08046032, when taken alone and when taken with another medicine called sasanlimab, for the treatment of advanced cancers. the effects are studied in adult participants with certain types of lymphomas or solid tumors that are advanced or metastatic (spread to other parts of the body). the study has three parts: * part a will test pf-08046032 alone at increasing dose levels in participants with certain lymphomas (cancer that begins in cells of the immune system) and in participants with certain solid tumors whose disease has worsened on or after standard treatments. * part b will test pf-08046032 (at selected doses) and sasanlimab in participants with certain solid tumors, including those whose disease has worsened on or after standard treatments as well as participants before receiving standard treatments. * part c will further test the combination of pf-08046032 and sasanlimab in participants with specific types of solid tumors based on the results from part a and part b of the study. all participants will receive the study drug pf-08046032. only participants in part b and part c of the study will also receive sasanlimab. pf-08046032 will be given as an intravenous (iv) infusion, which means it will be injected directly into a vein. sasanlimab will be given as a subcutaneous injection, which means it will be injected under the skin.


Eligibility criteria:
inclusion criteria: 1. histological or cytological diagnosis of metastatic or unresectable malignancy: * part a1: participants with lymphomas (chl, ptcl, large b-cell lymphoma) who have progressed on/after standard therapies * part a2: participants with solid tumors (nsclc, hnscc, melanoma, or other limited tumor types) who have progressed on or following prior immune checkpoint inhibitor if indicated and available * part b: participants with solid tumors who have either progressed on/after prior immune checkpoint inhibitor, or who have not received prior immune checkpoint inhibitor therapy * part c: participants with selected tumor type who have not received systemic anticancer treatment for the tumor type (including prior immune checkpoint inhibitor 2. measurable disease as defined by lugano classification for lymphomas or recist 1.1 for solid tumors 3. able to provide tumor tissue(s) as defined by the protocol depending on the part of the study at enrollment 4. ecog performance status score 0 or 1 exclusion criteria: 1. ongoing peripheral neuropathy 2. history of significant immune-mediated adverse event considered related to prior immune-modulatory therapy 3. known or suspected active autoimmune disease

Keywords: solid tumors advanced malignancies malignancies lung cancer skin cancer non-hodgkin lymphoma hodgkin lymphoma advanced cancers head and neck cancer metastatic cancer blood cancer
corneal lenticule implantation in keratoconus disease with relex smile surgery

Conditions: Keratoconus

Summary: corneal lenticule implantation in keratoconus disease with relex smile surgery

purpose: the purpose of our study is to investigate the feasibility and effect of fresh lenticule implantation as allogenic graft that will be taken from myopic patients, in order to implant in patients with keratocouns disease using visumax femtosecond laser - smile module surgery which primary objective in to increase central corneal thickness and secondary objective is to improve visual acuity and reducing k-values. methods: all the patients were clinically diagnosed with progressive keratoconus. twenty (20) patients underwent smile surgery (first group), and twenty (20) patients underwent lenticule implantation (second group). visual acuity, corneal topography, electron microscop,anterior segment optical coherence tomography, were analyzed. outcome: central corneal thickness were improved at the same day of surgery and vision started to improve at first week postoperatively in the second group (lenticule implant group). corneal topography showed a statistically significant decrease in the anterior k1 and k2. all the grafts from both groups were clearly visible by anterior segment optical coherence tomography observation and electron microscope. the central corneal thickness was stable during the 6-month study period. no complications were observed during short term follow-up. opinion: in our opinion, the present study may suggest that this procedure, using fresh lenticule with stromal stem cells and live keratocites is safe, reliable, and effectively increases corneal thickness and improves visual acuity with no adverse effects, which may provide new avenues in the treatment of corneal ectasia. key words: keratoconus,small incision,fresh lenticule, stromal implantation,stromal stem cells, smile surgery

Eligibility criteria:
inclusion criteria: * patients clinically diagnosed with progressive keratoconus exclusion criteria: * active anterior segment pathologic features, corneal thickness over 420, previous corneal or anterior segment surgery

Keywords: keratoconus small incision fresh lenticule stromal implantation stromal stem cells smile surgery
with continuity of covid-19 pandemic, have our anethetic choices for caesrean section changed ?

Conditions: COVID-19 Pandemic

Summary: this retrospective analytic study will be petformed to investigate if there was a change in the choice of anaethetic technique for caesarean sections with continuation of the covid-19 pandemic .

the number of regional and general anethesia techniques used with detailed number ofspinals epidurals as well as combined spinal epidurals that were provided .

Eligibility criteria:
inclusion criteria: * pregnant women * suspected or infected with covid-19 * women undergo cesarean section . exclusion criteria: * normal delivery * abortion
st.jude medical cardiac lead assessment study

Conditions: Externalized Conductors; Visual Lead Anomalies; Electrical Dysfunction

Summary: the cardiac lead assessment study (clas) is designed as a prospective, non-randomized, multi-center, international postmarket surveillance study under 522 order ps120111 (august 16, 2012).

the objective of this study was to determine the prevalence and incidence of externalized conductors and other visual lead anomalies (as evidenced by imaging) and the risk of progression to electrical dysfunction in subjects with one or more of the following st. jude medical (sjm) cardiac leads: riata leads, riata st leads, durata and/or quicksite/quickflex cardiac resynchronization therapy (crt) leads.

Eligibility criteria:
inclusion criteria: 1. patient has a market released sjm implantable cardioverter defibrillator (icd), crt-d or crt-p already implanted. 2. patient has at least one market released riata/ riata st/quicksite/quickflex/durata already implanted in which the lead model number and lead implant date is indicated in table 1 (see protocol attached.) 3. have the ability to provide informed consent for study participation and be willing to comply with the prescribed evaluations as detailed in this study plan. 4. are 18 years or above exclusion criteria: 1. patient is currently pregnant. 2. enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by sjm, during the course of this clinical study

Keywords: externalized conductors, visual lead an
a study to demonstrate bioequivalence between 6 x 2 mg tablets of perampanel and a single 12 mg tablet of perampanel in healthy subjects

Conditions: Partial Onset Epilepsy

Summary: the purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects.

a single centre, open label, 2-period, 2-sequence crossover bioequivalence study in one group of 28 subjects.

Eligibility criteria:
inclusion criteria: * healthy male or female subjects aged between 18-55 years. * bmi of 18-32 kg/m \^2. * willing and able to provide written informed consent. exclusion criteria: * subjects taking prescribed or over the counter (otc) medications in 2 weeks prior to screening. * subjects on special diets or dietary aids known to modulate drug metabolizing enzymes. * subjects who have taken inhibitor of cyp450 within 2 weeks of first dose. * subjects who have received any experimental drug in the 12 weeks prior to study drug treatment. * subjects with a history of alcohol abuse or who drink more than the recommended number of alcohol units per week. * subjects who consume more than five caffeinated beverages per day. * subjects who smoke more than 5 cigarettes per day. * subjects with a history of drug abuse or who have a positive urine drug screening test. * women who do not agree to use two methods of contraception.

Keywords: epilepsy
immune dysregulation in hepatitis c patients with or without arthritis

Conditions: Hepatitis C Patients

Summary: the purpose of this study is to study the role of the immune system in causing arthritis in patients with hepatitis c.

patients will provide one blood sample after qualifying for the study, and signing consent. the patients will have a skin test tb, candida, and trichophyton placed and will read the results themselves and mail back the card with the measurements to be recorded. labs will test for esr, cbc, crp, anticcp, cryoglobulins, rf, ch50, c3, c4, flow cytometry, and would have already been tested for hiv and hepatitis c.

Eligibility criteria:
inclusion criteria: * all adults 18 or older, 20 will have hep c positive with a viral load withen 6 mo. of enrollment. * either interferon or antiviral naive or those who failed interferon or antiviral therapy more than 6 mo. prior to enrollment. * 10 normal healthy controls- hep c neg and without osteoarthritis (oa). exclusion criteria: * hiv patients * those with concomitant alcoholic liver disease * patients with rheumatoid arthritis (ra) or other autoimmune disorders.

Keywords: hepatitis c arthritis
the efficacy of silymarin on the prevention of hepatotoxicity from antituberculosis drugs

Conditions: Tuberculosis

Summary: hepatitis is one of the most common adverse effect from anti-tuberculosis. silymarin showed its efficacy to decreased serum alanine transaminase enzyme in animal models from recent study. no confirmed this efficacy was performed in human. a prospective, double-blind, placebo-controlled trial was carried out according to good clinical practice guideline. this study is to define the efficacy of silymarin to prevent hepatotoxicity from anti-tuberculosis drugs. informed consent is obtained prior to the study. new patients diagnosed with tuberculosis are enrolled. patients with liver diseases, current alcohol drinking more than 20 g/day, regular use of herbal or other potential hepatotoxic drugs are excluded. patients are treated with a standard regimen of four anti-tuberculosis therapy. they will randomize to receive either placebo or silymarin (140 mg) thrice daily. liver function test (lft) and clinical changes are assessed at 2- and 4-week after initiation of the treatment. dili from anti-tuberculosis drugs ('atb-dili') is defined as: i) a rise of alanine aminotransferase (alt) to 2 times above normal upper limit, or ii) an elevation of total bilirubin more than 2 mg/dl with or without alt elevation. the study endpoints are the level of alt by week 4 and the number of patients who developed atb-dili. statistical analysis is used to compare the differences in alt and number of atb-dili

- prevention of antituberculosis-related drug induced liver injury with silymarin is investigated.

Eligibility criteria:
inclusion criteria: * tuberculosis cases * treated with isoniazid, rifampicin, ethambutol and pyrazinamide exclusion criteria: * no known liver disease (hbv, hcv), and hiv infection * normal alt level before enrollment * refuse to participate

Keywords: drug-induced liver injury tuberculosis silymarin
nursing interventions following sudden cardiac arrest

Conditions: ICD

Summary: determine the benefits of implantable cardioverter defibrillator (icd) patients participating in a structured, 8-week educational telephone intervention delivered by expert cardiovascular nurses post-icd. to determine if individuals participating in a post-hospital telephone nursing intervention would demonstrate (1) increased physical functioning, (2) increased psychological adjustment, (3) improved self-efficacy in managing the challenges of icd recovery, and (4) lower levels of health care utilization over usual care at 1, 3, 6 and 12 months post-icd implantation.

the goal of the study was to determine if a short-term social cognitive theory intervention would improve physical functioning and enhance psychological adjustment after receiving a first time icd. the central aim of this study was to determine if individuals participating in a telephone nursing intervention compared to usual care demonstrated (1) improved physical functioning, (2) improved psychological adjustment, 3) improved knowledge related to sudden cardiac arrest (sca) and the icd, and (4) lower levels of health care use over a 3-month period post-icd.

Eligibility criteria:
inclusion criteria: * the ability to read, speak, and write english, * having telephone access, * willingness to be followed for 1 year. exclusion criteria: * significant clinical comorbidities that prevented their return home after hospitalization, * younger than 21 years of age, * short blessed cognitive screening tool scores ≥10.
acoart paclitaxel svd:paclitaxel coated coronary balloon catheter in treatment of coronary small vessel diseases

Conditions: Coronary Disease

Summary: the purpose of the trial is to determine whether dcb made by acotec scientific is not inferior to restore deb made by cardionovum gmbh in treatment of small vessel coronary disease.

this is a prospective, multi-center, randomized-controlled clinical trial to verify the efficacy and safety of dcb made by acotec scientific versus restore deb in treatment of small vessel coronary disease. and the primary endpoint is angiographic restenosis at 9 months post-procedure.

Eligibility criteria:
inclusion criteria: * 18 to 80 years of age * subjects with symptomatic coronary artery disease with stable and unstable angina pectoris or secondary evaluation of stenosis after acute myocardial infarction (mi) and asymptomatic subjects with coronary atherosclerotic stenosis causing myocardial ischemia determined by the investigator * subjects with single, de novo lesion with stenosis of more than 70% (or more than 50% combined with symptoms of ischemia) in a vessel with visually estimated reference vessel diameter (rvd) ≥ 2.00 mm and ≤ 2.75 mm, and ≤ 26 mm in length. * subject must agree to clinical follow-up at 1, 6, 9, 12 months, and angiographic follow-up at 9 months. * subject can understand the study objectives psychologically and linguistically and shows sufficient compliance to the study protocol. subjects express acceptance of the risks and benefits described in the informed consent form. exclusion criteria: * ami within 1 week. * subject has congestive heart failure or nyha iv. * subject with lvef \< 35%. * subject has undergone heart transplantation. * subject has cardiac arrhythmias, such as high-risk ventricular premature beat and/or ventricular tachycardia. * subject suffered stroke, gastrointestinal bleeding or active ulcer within the past 6 months, or with conditions associated with high risk of bleeding. * subject with a history of leukopenia (white blood cell count of \ 3 days), neutropenia (anc\ 3 days) or thrombocytopenia (platelet \<100,000/mm3). * known renal insufficiency (egfr\<30 ml/min). * subject who is forbidden to use anticoagulation agents or anti-platelet drugs, and tolerate aspirin or clopidogrel. * life expectancy less than 12 months, or subjects who cannot complete 12-month follow-up. * pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. * subject is currently participating in another investigational drug or device study that has not yet completed its primary endpoint. * subject unsuitable for study according to the investigator due to the investigator due to other reasons related to diseases. * angiography exclusions:target lesion: total occlusion lesion (timi 0), heavy calcified lesion that cannot be successfully dilated, bifurcation lesion (side branch ≥ 2.0 mm in diameter), restenosis lesion, thrombotic lesion, or left main disease;non-target lesion: more than 2 non-target lesions or non-target lesion cannot be successfully treated.

Keywords: coronary small vessel diseases dcb
a study of the safety, tolerability, and antiretroviral activity of raltegravir (mk-0518) in combination with other antiretroviral therapies in russian children and adolescents infected with human immunodeficiency virus (hiv-1) (mk-0518-248)

Conditions: HIV Infection

Summary: this multicenter, open-label, noncomparative study evaluates two oral formulations of raltegravir (mk-0518, film-coated tablet and chewable tablet) in combination with other antiretroviral agents for safety, tolerability, and antiretroviral activity in treatment-naive or treatment-experienced russian children and adolescents infected with human immunodeficiency virus-1 (hiv-1). as raltegravir is indicated in combination with other antiretroviral therapies (arts) for the treatment of hiv-1 infection in pediatric patients in the united states (us), this study is designed to gain local treatment experience on the use of raltegravir in the pediatric hiv-infected population in russia.


Eligibility criteria:
inclusion criteria: * hiv positive * weight of at least 7 kg * hiv rna ≥1000 copies/ml within 45 days before study treatment * participants of reproductive potential and sexually active agree to remain abstinent or use (or have their partner use) an acceptable method of birth control throughout the study. exclusion criteria: * females pregnant or breast-feeding, or expecting to conceive or donate eggs during the study; males planning to impregnate or provide sperm donation during the study * use of any non-antiretroviral (art) investigational agents within one month before study treatment * current (active) diagnosis of acute hepatitis or chronic hepatitis other than stable chronic hepatitis b and/or c * prior or current use of raltegravir * use of another experimental hiv-integrase inhibitor * history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with participation for the full duration of the study * requires or is anticipated to require any prohibited medications * use of immunosuppressive therapy within 30 days before beginning raltegravir study treatment; short courses of corticosteroids are permitted. * history of malignancy * current treatment for active tuberculosis infection * use of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse or dependence